1.This Act may be cited as the
Strategies to Address Antimicrobial
Resistance Act
.
2.The Congress finds as follows:
(1)The advent of the
antibiotic era has saved millions of lives and allowed for incredible medical
progress; however, the increased use and overuse of antimicrobial drugs have
correlated with increased rates of antimicrobial resistance.
(2)Through mutation
as well as other mechanisms, bacteria and other infectious disease-causing
organisms—viruses, fungi, and parasites—develop resistance to antimicrobial
drugs over time. The more antimicrobial drugs are used, whether appropriately
or inappropriately, the more this contributes to the development of
antimicrobial resistance.
(3)Scientific
evidence suggests that the source of antimicrobial resistance in humans is not
just limited to use of antimicrobial drugs in humans, but may in fact also be
from food-producing animals which are exposed to antimicrobial drugs.
(4)A study estimates
that in 2005 more than 94,000 invasive methicillin-resistant Staphylococcus
aureus (MRSA) infections occurred in the United States and more than 18,500 of
these infections resulted in death.
(5)Each year, nearly
2,000,000 people contract bacterial infections in hospitals and approximately
90,000 of these people die from these infections.
(6)The costs of
antimicrobial-resistant bacterial diseases are hard to quantify, but a 1995
report by the Office of Technology Assessment of and agency of Congress, which
looked at 6 different antimicrobial-resistant strains of bacteria, calculated
that the minimum nationwide hospital costs of just these strains of bacteria
accounted for $1,300,000,000 annually in 1992 dollars ($1,870,000,000 in 2006
dollars).
(7)The cost to
society of antimicrobial-resistant infections will only rise as antimicrobial
resistance continues to spread.
3.Antimicrobial
Resistance Task Force
(a)Section 319E of the
Public Health Service Act (42 U.S.C. 247d–5) is
amended—
(1)in subsection
(a)—
(A)in the subsection heading, by striking
Task
force
and inserting the following:
Office of Antimicrobial
Resistance, Task force, and Advisory Board
;
(B)in paragraph
(1)—
(i)by
striking as of the date of the enactment of this section
and
inserting September 30, 2006
; and
(ii)by
adding at the end the following: The Secretary shall, not later than 1
year after the date of enactment of the Strategies to Address Antimicrobial Resistance
Act, establish an Office of Antimicrobial Resistance in the
Office of the Secretary and appoint a director to that Office. The Secretary
shall, not later than 1 year after the date of enactment of such Act, establish
the Public Health Antimicrobial Advisory Board as an advisory board to the
Director of the Office of Antimicrobial Resistance. The Director of the Office
of Antimicrobial Resistance shall serve as the Director of the task force and
supervise the activities of the Office, task force, and advisory
board.
;
(C)by amending paragraph (2) to read as
follows:
(2)
(A)Members of the
Antimicrobial Resistance Task ForceThe task force described in paragraph (1)
shall be composed of representatives of such Federal agencies as the Secretary
determines necessary, including representation of the following:
(i)The Office of Antimicrobial
Resistance.
(ii)The Assistant
Secretary of Preparedness and Response.
(iii)The Centers for
Disease Control and Prevention.
(iv)The Food and Drug
Administration.
(v)The National
Institutes of Health.
(vi)The Agency for
Healthcare Research and Quality.
(vii)The Centers for
Medicare & Medicaid Services.
(viii)The Health
Resources and Services Administration.
(ix)The Department of
Agriculture.
(x)The Department of
Education.
(xi)The Department of
Defense.
(xii)The Department of
Veterans Affairs.
(xiii)The
Environmental Protection Agency.
(xiv)The Department
of Homeland Security.
(B)Members of the
public health antimicrobial advisory board
(i)The Public Health Antimicrobial Advisory Board shall be
composed of 13 voting members, appointed by the Secretary. Such members shall
include experts from the medical professions (including hospital and
community-based physicians), public health, veterinary, research, and
international health communities.
(ii)Each
member appointed under clause (i) shall be appointed for a term of 3 years,
except that of the 13 members first appointed—
(I)4 shall be
appointed for a term of 12 months; and
(II)4 shall be
appointed for a term of 2 years.
(iii)The
Secretary shall appoint a Chair of the Public Health Antimicrobial Advisory
Board from among its members to lead and supervise the activities of the
advisory
board.
;
(D)in paragraph
(3)(B), by striking in consultation with the task force described in
paragraph (1) and
and inserting acting through the Director of
the Office of Antimicrobial Resistance and the Director of the Centers for
Disease Control and Prevention, and in consultation with
; and
(E)by amending
paragraph (4) to read as follows:
(4)
(A)Office of
antimicrobial resistance dutiesThe Director of the Office of Antimicrobial
Resistance, working in conjunction with the Federal agencies that are
represented on the task force described in paragraph (1), shall issue an update
to the Public Health Action Plan to Combat Antimicrobial Resistance within 18
months of the establishment of the Office and biennial updates thereafter. The
updates shall include enhanced plans for addressing antimicrobial resistance in
the United States and internationally. The Director of the Office shall post on
a website these updates as well as summaries of all non-proprietary data the
Task Force makes available. The Director of the Office of Antimicrobial
Resistance shall, as appropriate—
(i)establish
benchmarks for achieving the goals set forth in the action plan;
(ii)assess the
ongoing, observed patterns of emergence of antimicrobial resistance, and their
impact on clinical outcomes in terms of how patients feel, function, or
survive;
(iii)assess how
antimicrobial products are being used in humans, animals, and plants, and the
impact of such use in furthering the development of resistance and the
implications thereof for patient safety and public health;
(iv)establish a
priority list of human infectious diseases with the greatest need for
development of new point-of-care and other diagnostics, antimicrobial drugs,
and vaccines, and in particular serious and life-threatening bacterial
diseases, for which there are few or no diagnostic or treatment options;
(v)recommend basic,
clinical, epidemiological, prevention, and translational research where
additional federally supported studies may be beneficial;
(vi)recommend how to
support antimicrobial development through the Food and Drug Administration’s
Critical Path Initiative;
(vii)recommend how
best to strengthen and link antimicrobial resistance-related surveillance and
prevention and control activities; and
(viii)collaborate
with the Assistant Secretary for Preparedness and Response to ensure that
strategies to address antimicrobial-resistance are coordinated with initiatives
aimed at Severe Acute Respiratory Syndrome, bioterrorism, and other emerging
health threats.
(B)Antimicrobial
resistance task force meetings and duties
(i)The
Antimicrobial Resistance Task Force shall convene periodically as the Director
of the Antimicrobial Resistance Task Force determines to be appropriate, but
not fewer than twice a year, to consider issues relating to antimicrobial
resistance.
(ii)Public health
action planAt least twice a year, the task force shall have a
meeting to review, discuss, and further develop the Public Health Action Plan
to Combat Antimicrobial Resistance issued by the interagency task force on
antimicrobial resistance in 2001. Among other issues, the task force may
discuss and review, based on current need or concern—
(I)antimicrobial
clinical susceptibility concentrations proposed, established, or updated by the
Food and Drug Administration;
(II)data obtained by
government agencies and, as possible, by private sources on emerging
antimicrobial resistance related to clinical outcomes in terms of how patients
function, feel, or survive as well as data related to how antimicrobial drugs
may have been used inappropriately;
(III)surveillance
data and prevention and control activities regarding emerging antimicrobial
resistance from reliable sources including the Centers for Disease Control and
Prevention, the Food and Drug Administration, the Department of Defense, the
Department of Veterans Affairs, the Department of Agriculture, the
Environmental Protection Agency, and as feasible from private sources and
international bodies;
(IV)data on the
amount of antimicrobial products used in humans, animals, and plants from
reliable sources including data from the Centers for Disease Control and
Prevention, the Food and Drug Administration, the Environmental Protection
Agency, the Department of Veterans Affairs, the Centers for Medicare &
Medicaid Services, the Department of Homeland Security, and the Department of
Agriculture, and as feasible from private sources and international
bodies;
(V)reports of
federally supported antimicrobial resistance research and antimicrobial drug
development research activities (including clinical, epidemiological,
prevention, and translational research) obtained from Federal agencies, as well
as reports of research sponsored by other countries, industry, and
non-governmental organizations;
(VI)reports on
efforts by the Food and Drug Administration to develop policies and guidances
which encourage antimicrobial drug development and appropriate use while
maintaining high standards for safety and effectiveness;
(VII)health plan
employer data and information set (HEDIS) measures pertaining to appropriate
use of antimicrobial drugs; and
(VIII)other data and
issues the task force identifies as relevant to the issue of antimicrobial
resistance.
(iii)The Food and Drug Administration may consult with
the Director of the Office of Antimicrobial Resistance concerning the pending
application of any antimicrobial drug application submitted to the Secretary
under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act or the
Public Health Service Act.
(C)Public health
antimicrobial advisory board meetings and duties
(i)The
Public Health Antimicrobial Advisory Board shall meet as the Chair of the
Public Health Antimicrobial Advisory Board determines to be appropriate, but
not fewer than 2 times each year.
(ii)The
Public Health Antimicrobial Advisory Board shall make recommendations to the
Secretary, and the Office of Antimicrobial Resistance, regarding—
(I)ways to encourage
the availability of an adequate supply of safe and effective antimicrobial
products;
(II)research
priorities and other measures (such as antimicrobial drug resistance management
plans) to enhance the safety and efficacy of antimicrobial products;
(III)how best to
implement and update the goals of the Public Health Action Plan to Combat
Antimicrobial Resistance;
(IV)incentives
necessary to establish uniform mechanisms and data sets for State reporting of
resistance data;
(V)the adequacy of
existing surveillance systems to collect antimicrobial resistance data and how
best to improve the collection, reporting, and analysis of such data;
(VI)the development
of a national plan for the collection and analysis of isolates of resistant
pathogens, including establishing priorities as to which isolates should be
collected;
(VII)the
implementation and evaluation of interventions to promote appropriate
antimicrobial drug use in both inpatient and outpatient settings; and
(VIII)areas for
government, nongovernment, and international cooperation to strengthen
implementation of the Public Health Action Plan to Combat Antimicrobial
Resistance.
(D)Availability of
informationThe Office of Antimicrobial Resistance shall ensure
that all information shall be made available to the public on the website
described in subparagraph (A) consistent with section 7 of the
Strategies to Address Antimicrobial
Resistance
Act.
;
(2)by amending
subsection (b) to read as follows:
(b)Antimicrobial
resistance research and product developmentThe Secretary, acting
through the Director of the Office of Antimicrobial Resistance, the Director of
the Centers for Disease Control and Prevention, and the Director of the
National Institutes of Health, and in consultation with other Federal agencies,
shall develop an antimicrobial resistance strategic research plan that
strengthens existing epidemiological, interventional, clinical, behavioral,
translational, and basic research efforts to advance the understanding
of—
(1)the development,
implementation, and efficacy of interventions to prevent and control the
emergence and transmission of antimicrobial resistance;
(2)how best to
optimize antimicrobial effectiveness while limiting the emergence of
resistance, including addressing issues related to duration of therapy,
effectiveness of therapy in self-resolving diseases, and determining
populations most likely to benefit from antimicrobial drugs;
(3)the extent to which
the use of antimicrobial products in humans, animals, plants, and other uses
accelerates development and transmission of antimicrobial resistance;
(4)the natural
histories of infectious diseases (including defining the disease, diagnosis,
severity, and the time course of illness);
(5)the development of
new therapeutics, including antimicrobial drugs, biologics, and devices against
resistant pathogens, and in particular diseases for which few or no
therapeutics are in development;
(6)the development
and testing of medical diagnostics to identify patients with infectious disease
and identify the exact cause of infectious diseases syndromes, particularly
with respect to the detection of pathogens resistant to antimicrobial
drugs;
(7)the epidemiology,
pathogenesis, mechanisms, and genetics of antimicrobial resistance; and
(8)the sequencing of
the genomes, or other DNA analysis, or other comparative analysis of priority
pathogens (as determined by the advisory board), in collaboration with the
Department of Defense and the Joint Genome Institute of the Department of
Energy.
;
and
(3)in subsection
(c)—
(A)by inserting
acting through the Director of the Office of Antimicrobial
Resistance,
after The Secretary,
; and
(B)by striking
members of the task force described in subsection (a),
;
(4)in subsection
(d)(1), by inserting , through the Office of Antimicrobial
Resistance,
after The Secretary
; and
(5)in subsection
(e)—
(A)in paragraph (1),
by inserting , acting through the Director of the Office of
Antimicrobial Resistance,
after The Secretary
;
(B)in paragraph (3),
by inserting , acting through the Office of Antimicrobial
Resistance,
after The Secretary
; and
(C)by adding at the
end the following:
(4)Preference in
making awardsIn making awards under paragraph (1), the Secretary
shall give preference to eligible entities that will use grant funds to
establish demonstration projects to assess the scope of the antimicrobial
resistance problem and the level of appropriate and inappropriate use of
antimicrobial drugs especially related to acute bacterial otitis media and
upper respiratory infections, and in particular acute exacerbation of chronic
bronchitis, including the validation of models that may lead to the development
of quality measures for health care providers prescribing antimicrobial
drugs.
.
(b)Ensure access
to antimicrobial data and researchThe Director of the Office of
Antimicrobial Resistance shall work with the agencies represented on the
Antimicrobial Resistance Task Force to identify relevant data and formats, and
mechanisms for communicating such data to the Office of Antimicrobial
Resistance and the Antimicrobial Resistance Task Force, including relevant data
obtained by the agencies through contracts with other organizations,
including—
(1)use and clinical
outcomes data on patients receiving antimicrobial drugs for the treatment,
prevention, or diagnosis of infection or infectious diseases;
(2)surveillance data
regarding emerging antimicrobial drug resistance;
(3)susceptibility
data related to antimicrobial drug use;
(4)data related to
the amount of antimicrobial products used in humans, animals, and
plants;
(5)data from
federally funded research intended to support antimicrobial drug
development;
(6)data demonstrating
the impact of research, surveillance, and prevention and control initiatives in
understanding and controlling antimicrobial resistance; and
(7)data regarding
implementation and evaluation of interventions to improve antimicrobial drug
prescribing practices.
4.Collection of
antimicrobial drug data
(a)Submission of
human and animal drug distribution dataChapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 512 the following:
512A.Submission of
human and animal drug distribution data
(a)Notwithstanding any
other provision of law, the Secretary shall require that human drug
distribution data required to be submitted for each calendar year under section
314.81(b)(ii) of title 21, Code of Federal Regulations (or any successor
regulation) and the animal drug distribution data required to be submitted for
each such calendar year under section 514.80(b)(4)(i) of title 21, Code of
Federal Regulations (or any successor regulation) be—
(1)submitted not later than 60 days after the
beginning of the subsequent calendar year; and
(2)made available to the Office of
Antimicrobial Resistance, the Antimicrobial Resistance Task Force, and the
Public Health Antimicrobial Advisory Board.
(b)The Office of Antimicrobial Resistance, the
Antimicrobial Resistance Task Force, and the Public Health Antimicrobial
Advisory Board shall sign a confidentiality agreement to protect proprietary
information made available under subsection
(a)(2).
.
(b)
(1)The Secretary, acting through the Director of the Office
of Antimicrobial Resistance, shall explore opportunities to secure from private
vendors reliable and comparable animal and human antimicrobial drug consumption
data (volume antimicrobial distribution data and antimicrobial use, including
prescription data) by State or metropolitan area, as necessary, to supplement
the antimicrobial drug consumption data to be collected under this section for
the purpose of demonstrating how the consumption of antimicrobial drugs for
human and animal uses may affect the development of resistance over time and
within geographic locations and to institute preventive interventions.
(2)The
Director of the Office of Antimicrobial Resistance may enter into negotiations
with private vendors to determine acceptable formats for making summaries of
antimicrobial drug consumption data that is collected under this section
publicly available for research purposes while maintaining the confidentiality
of any proprietary commercial data.
(3)Other means to
secure dataIf the Director of the Office of Antimicrobial
Resistance is not able to secure sufficient supplemental antimicrobial drug
consumption data for human and animal uses through private vendors as provided
for in this section, the Secretary shall consider other means to secure such
consumption data, including through the conduct of surveys about how
antimicrobial drugs are used in various settings and make such data available
to the public consistent with section 7.
(c)Collection of
antimicrobial prescription data
(1)The Director of the Office of Antimicrobial
Resistance shall work with the Under Secretary for Health of the Department of
Veterans Affairs and the Administrator of the Centers for Medicare &
Medicaid Services to collect relevant drug utilization data and clinical
outcomes data, as determined relevant by the Director of the Office of
Antimicrobial Resistance, on patients who receive services funded by such
agencies and who are receiving prescription antimicrobial agents for the
treatment, prevention, or diagnosis of infection or infectious diseases.
(2)Any
data collected under paragraph (1) shall be organized by—
(A)indication
(including results of diagnostic studies when available);
(B)dosage;
(C)route of
administration;
(D)duration;
(E)age of the
patient; and
(F)geographic
region.
(d)Public
availability of summariesThe Director of the Office of
Antimicrobial Resistance shall make summaries of the data received under this
section publicly available by antimicrobial drug class and ensure that such
summaries are updated and published, in a manner consistent with section 7, at
least once annually on the website described in section 319E(a)(4)(A) of the
Public Health Service Act (42 U.S.C. 247d–5(a)(4)(A)) in order to support
epidemiologic and microbiologic research. In the case of an antimicrobial drug
class where only one antimicrobial drug has been approved, such summary data
shall not be made public.
5.Antimicrobial
resistance clinical research and public health network
(a)The Secretary,
through the Director of the Centers for Disease Control and Prevention and the
Director of the National Institutes of Health, shall establish at least 10
Antimicrobial Resistance Clinical Research and Public Health Network sites to
strengthen the national capacity to—
(1)describe and confirm regional outbreaks
through surveillance of locally available clinical specimens;
(2)assess, integrate, and address local and
national antimicrobial resistance patterns;
(3)facilitate research on prevention, control,
and treatment of resistant organisms; and
(4)serve as a clinical trials network for
optimizing antimicrobial drug effectiveness.
(b)The sites
established under subsection (a) shall be geographically distributed across the
United States, based in academic centers, health departments, and existing
surveillance sites.
(c)The sites established under subsection (a)
shall—
(1)monitor the emergence and changes in the
patterns of antimicrobial resistant pathogens in individuals;
(2)study the molecular epidemiology of such
pathogens;
(3)evaluate the efficacy of new and existing
interventions to prevent or limit the emergence of antimicrobial resistance
throughout the geographic region of the site;
(4)provide to the Centers for Disease Control
and Prevention isolates of resistant pathogens, and in particular, pathogens
that show new or atypical patterns of resistance adversely affecting public
health;
(5)conduct clinical research to develop
natural histories of infectious disease and to study duration of antimicrobial
use related to resistance development, among other things;
(6)assess the feasibility, cost-effectiveness,
and appropriateness of surveillance and screening programs in differing health
care and institutional settings, such as schools; and
(7)evaluate current treatment protocols and
make appropriate recommendations on best practices for treating drug resistant
infections.
(d)The sites established under subsection (a)
may share data and cooperate with the Centers for Disease Control and
Prevention and the National Institutes of Health.
(e)The Director of the
Centers for Disease Control and Prevention and the Director of the National
Institutes of Health shall ensure that summary reports of data obtained by the
Antimicrobial Resistance Clinical Research and Public Health Network sites are
made accessible to the Antimicrobial Task Force for review on an ongoing
basis.
6.Authorization of
appropriationsSection 319E(g)
of the Public Health Service Act (42 U.S.C. 247d–5(g)) is amended
to read as follows:
(g)Authorization of
appropriations
(1)There
are authorized to be appropriated to carry out this section (other than
subsection (b)) $45,000,000 for fiscal year 2008, $65,000,000 for fiscal year
2009, $120,000,000 for fiscal year 2010, and such sums as may be necessary for
each subsequent fiscal year.
(2)Of
the amount appropriated to carry out this section for a fiscal year, not less
than one-third of such amount shall be made available for activities of the
Centers for Disease Control and Prevention under subsections (a)(3)(B) and (c),
of which at least one-third of such amount shall be made available for the
Centers for Disease Control and Prevention educational programs dedicated to
the reduction of inappropriate antimicrobial
use.
.
7.Protection of
confidential and national security informationExcept as otherwise required by law, this
Act (and the amendments made by this Act) shall not permit public disclosure of
trade secrets, confidential commercial information, or material inconsistent
with national security that is obtained by any person under this Act.